Австралія - англійська - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - azithromycin dihydrate, quantity: 524.1 mg (equivalent: azithromycin, qty 500 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; maize starch; sodium lauryl sulfate; sodium starch glycollate type a; colloidal anhydrous silica; lactose monohydrate; hypromellose; titanium dioxide; macrogol 4000 - azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity: 1. lower respiratory tract infections: acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenzae or moraxella catarrhalis.community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment. community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae. 2. upper respiratory tract infections: acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae. acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. uncomplicated skin and skin structure infections: uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage. 4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis. . note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other medicines for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma. azithromycin is also indicated for the prevention of infection due to mycobacterium avium-intracellular complex (mac) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with hiv infection and cd4 cell count less than or equal to 75 cells/microliter (see precautions). disseminated infection due to mycobacterium avium-intracellular complex should be excluded by a negative blood culture prior to commencement of therapy.

США - англійська - NLM (National Library of Medicine)

department of state health services, pharmacy branch - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influen

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - azithromycin dihydrate, quantity: 524.1 mg (equivalent: azithromycin, qty 500 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; magnesium stearate; maize starch; sodium lauryl sulfate; lactose monohydrate; hypromellose; titanium dioxide; macrogol 4000 - azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity: 1. lower respiratory tract infections: acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenzae or moraxella catarrhalis.community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment. community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae. 2. upper respiratory tract infections: acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae. acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. uncomplicated skin and skin structure infections: uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage. 4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis. . note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other medicines for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma. azithromycin is also indicated for the prevention of infection due to mycobacterium avium-intracellular complex (mac) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with hiv infection and cd4 cell count less than or equal to 75 cells/microliter (see precautions). disseminated infection due to mycobacterium avium-intracellular complex should be excluded by a negative blood culture prior to commencement of therapy.

США - англійська - NLM (National Library of Medicine)

medsource pharmaceuticals - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications . azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see dosage and administration ( 2)] .    - acute bacterial exacerbations of chronic bronchitis due to  haemophilus influenzae ,  moraxella catarrhalis , or streptococcus pneumoniae . - acute bacterial sinusitis due t

США - англійська - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis or streptococcus pneumoniae . - community-acquired pneumonia due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure infections due to staphylococcus aureus , streptococcus pyogenes , or streptococcus agalactiae . - urethritis and cervicitis due to chlamydia trachomatis or neisseria gonorrhoeae . - genital ulcer disease in men due to haemophilus ducreyi (chancroid). due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. [see use in specific populations (8.4) and clinical studies (14.2)] -   acute otitis media (>6 months of age) caused by haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae. -   community-acquired pneumonia (>6 months of age) due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae , or streptococcus pneumoniae in patients appropriate for oral therapy. -   pharyngitis/tonsillitis (>2 years of age) caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: - patients with cystic fibrosis, - patients with nosocomial infections, - patients with known or suspected bacteremia, - patients requiring hospitalization, - elderly or debilitated patients, or - patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. risk summary available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data: available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. animal data: azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. in rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area. in a pre-and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks). these effects were not observed in a pre-and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning. risk summary azithromycin is present in human milk (see data) . non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see clinical considerations) . there are no available data on the effects of azithromycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. clinical considerations advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. data azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing. in another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for cesarean section. breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. [see clinical pharmacology (12.3), indications and usage (1.2), and dosage and administration (2.2)] safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults. pharyngitis/tonsillitis safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. in multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. [see warnings and precautions (5.4)]  

США - англійська - NLM (National Library of Medicine)

major pharmaceuticals - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] [see use in specific populations (8.4) and clinical studies (14.2)] azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antiba

США - англійська - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin tablets, taken alone or in combination with rifabutin at its approved dose, are indicated for the prevention of disseminated mac disease in persons with advanced hiv infection [see dosage and administration (2)] . treatment of disseminated mac disease azithromycin tablets, taken in combination with ethambutol, are indicated for the treatment of disseminated mac infections in persons with advanced hiv infection [see use in specific populations (8.4) and clinical studies (14.1)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strong

США - англійська - NLM (National Library of Medicine)

remedyrepack inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration ( 2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis or streptococcus pneumoniae . - community-acquired pneumonia due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure infections due to staphylococcus aureus , streptococcus pyogenes , or streptococcus agalactiae . - urethritis and cervicitis due to chlamydia trachomatis or neisseria gonorrhoeae . - genital ulcer disease in men due to haemophilus ducreyi (chancroid). due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. [see use in specific populations ( 8.4) and clinical studies ( 14.2)] -   acute otitis media ( >6 months of age) caused by haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae. -   community-acquired pneumonia ( >6 months of age) due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae , or streptococcus pneumoniae in patients appropriate for oral therapy. -   pharyngitis/tonsillitis (>2 years of age) caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: - patients with cystic fibrosis, - patients with nosocomial infections, - patients with known or suspected bacteremia, - patients requiring hospitalization, - elderly or debilitated patients, or - patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. risk summary available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data: available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. animal data: azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. in rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area. in a pre-and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks). these effects were not observed in a pre-and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning. risk summary azithromycin is present in human milk (see data) . non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see clinical considerations) . there are no available data on the effects of azithromycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. clinical considerations advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. data azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing. in another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for cesarean section. breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. [see clinical pharmacology ( 12.3), indications and usage ( 1.2), and dosage and administration ( 2.2)] safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults. pharyngitis/tonsillitis safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. in multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients . [see warnings and precautions ( 5.4)]  

США - англійська - NLM (National Library of Medicine)

avpak - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis. or streptococcus pneumoniae . - community-acquired pneumonia due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure infections due to staphylococcus aureus , streptococcus pyogenes , or streptococcus agalactiae . - urethritis and cervicitis due to chlamydia trachomatis or neisseria gonorrhoeae . - genital ulcer disease in men due to haemophilus ducreyi (chancroid). due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. [see use in specific populations (8.4) and clinical studies (14.2)] - acute otitis media ( > 6 months of age ) caused by haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae - community-acquired pneumonia ( > 6 months of age ) due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumonia , or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/tonsillitis ( > 2 years of age ) caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: - patients with cystic fibrosis, - patients with nosocomial infections, - patients with known or suspected bacteremia, - patients requiring hospitalization, - elderly or debilitated patients, or - patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. risk summary available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. animal data azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. in rabbits administered azithromycin at oral doses of 10 mg/kg/day, 20 mg/kg/day, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area. in a pre- and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 mg/kg/day or 200 mg/kg/day. maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks). these effects were not observed in a pre- and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning. risk summary azithromycin is present in human milk (see data) . non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see clinical considerations) . there are no available data on the effects of azithromycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. clinical considerations advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. data azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing. in another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for cesarean section. breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. [see clinical pharmacology (12.3), indications and usage (1.2), and dosage and administration (2.2)] safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults. pharyngitis/tonsillitis: safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. in multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4,949) and 3% of patients (144/4,949) were at least 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. [see warnings and precautions (5.4)]

США - англійська - NLM (National Library of Medicine)

american health packaging - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis or streptococcus pneumoniae . - community-acquired pneumonia due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/t